In the bustling world of consumer products, the lines between certain kinds of cosmetics and drugs can sometimes become blurred, leaving manufacturers and consumers alike wondering about the primary distinctions between these categories. Understanding whether a product is considered a cosmetic, a drug, or both, is crucial for regulatory compliance, marketing, and for ensuring the safety and efficacy of these products in the marketplace.
What Does the FDA Law Define as a Cosmetic?
The Federal Food, Drug & Cosmetic Act (FD&C Act) defines cosmetics as
The articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.
Key takeaways from the definition:
- Intended Purpose: A product may be categorized as a cosmetic if its intended use involves applying it to the human body for cleansing, enhancing beauty, promoting attractiveness, or modifying appearance.
- Application Methods: The definition includes various application methods for external use, such as rubbing, pouring, sprinkling, or spraying.
- Non-Structural and Non-Functional function: To be classified as a cosmetic, the product must not have a primary function of affecting the body’s structure or functions. Their purpose does not involve diagnosing, treating, mitigating, curing, or preventing any diseases or medical conditions.
What is a Drug According to the FDA Law?
The FD&C Act defines drugs,
Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and articles (other than food) intended to affect the structure or any function of the body of man or other animals.
Key points of the definition:
- Intended Purpose: Drugs are products designed for usage in diagnosing, curing, mitigating, treating, or preventing diseases or medical conditions in humans or animals.
- Disease-Related Claims: A product can be a drug if marketed with claims related to its ability to address diseases or medical conditions.
- Impact on Disease: Drugs are designed to have a physiological effect on the body to address specific health issues, such as relieving symptoms, treating infections, managing chronic conditions, or curing diseases.
Is it possible for a product to qualify as both a cosmetic and a drug?
A product can be both a cosmetic and a drug when it is formulated and marketed to serve dual functions, the function of a cosmetic and a drug, in different circumstances or with different claims.
If a product claims to enhance beauty, improve appearance, or cleanse the skin without making any therapeutic claims, it is classified as a cosmetic. However, if the same product claims to treat acne, reduce wrinkles, or provide any other therapeutic effect, it falls under the definition of a drug.
For example, a moisturizing cream that claims to keep the skin hydrated and improve its texture would be classified as a cosmetic. But if the same cream makes claims to treat eczema or provide relief for dry or itchy skin due to an underlying medical condition, it would be considered both a cosmetic and a drug.
How to establish a product’s intended use?
There are several ways in which a product’s intended use is established:
- Marketing/Labeling Claims
- Product Composition and Formulation
- Perception among users
Claims on Product Labeling and Advertising
The most direct way to establish a product’s intended use is through the claims made on its labeling, advertising, websites, promotional materials, and product descriptions.
If certain claims suggest that the product is intended to treat, prevent disease, or alter the body’s functions, it may be considered a drug, regardless of its cosmetic marketing.
Understanding how consumers perceive and interpret the product’s purpose is essential. This involves investigating why consumers buy the product and what expectations they have regarding its effects.
Ingredients with Well-Known Therapeutic Uses
Some ingredients are well recognized amongst the public and across the industry for their therapeutic effects. If a product contains such ingredients, it may be classified as a drug.
For instance, acne cream with benzoyl peroxide, salicylic acid, or topical antibiotics like clindamycin, which have well-known therapeutic properties for treating acne and preventing acne-causing bacteria is an example of this.
Cosmetics vs. Drugs: Different Laws and Regulations?
The laws and regulations for cosmetics and drugs are different in several key aspects due to their distinct intended uses and potential impacts on human health.
Cosmetic products are regulated under
- FD&C Act
- Fair Packaging and Labeling Act (FPLA)
Conversely, the FDA regulates drugs under the FD&C Act alone.
Cosmetic products are primarily regulated by the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), whereas Drug products are regulated by the FDA’s Center for Drug Evaluation and Research (CDER).
Approvals for Marketing Authorization
Earlier until 2021, the FDA had a program – The Voluntary Cosmetic Registration Program for cosmetic manufacturers to voluntarily register their products and ingredients.
However, on March 27, 2023, the FDA ceased accepting and processing applications due to the FDA’s intention to establish a new program for facility registrations and product listings as required by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). As a part of the MoCRA, the FDA shall be establishing mandatory Good Manufacturing Requirements (GMP) regulations, unless exempted.
The FDA is yet to release final set of requirements for registration and listing cosmetic products. By December 29, 2024, the FDA plans to release a notice of proposed rulemaking related to the GMPs, and a final rule by December 29, 2025. Until that point, the manufacturer bears the responsibility of ensuring the product’s safety and effectiveness for use.
There are different types of applications that drug manufacturers should file before marketing the drugs. The FDA carefully examines the application to guarantee the drug’s safety and effectiveness. Below are the kinds of drugs and the corresponding application that must be sent to the FDA for a review and approval. There are exemptions, which one can explore based on the precise drug characteristics and intended use.
For New Drugs:
- New Drug Application (NDA)
For Generic Drugs:
- Abbreviated New Drug Application (ANDA)
For Over-the-Counter Drugs:
- OTC Monograph
Want to understand more about FDA applications for drug approvals? Contact us.
Good Manufacturing Practices (GMP):
While there is draft guidance from the FDA for GMP in the cosmetic industry, the FDA is yet to release final guidelines. However, its important that the manufacturers understand the FDA’s expectations for GMP for cosmetics. Write to us to help you audit your system using our GMP checklist, years of experience, and an understanding of the FDA expectations from cosmetic companies.
Drugs must strictly adhere to GMP requirements outlined by the FDA to ensure consistent quality, safety, and efficacy of drug products. Failure to comply with GMP requirements renders a drug adulterated.
Cosmetic labeling requirements focus on providing essential information to consumers, such as the product identity, net quantity, ingredient list, and any necessary warnings or directions for safe use.
Figuring labeling requirements for your cosmetic product? Visit us here.
Drug labeling must include comprehensive information about the drug’s uses, indications, dosage, contraindications, warnings, and potential side effects. The label must provide clear and accurate information to guide healthcare professionals and patients in using the drug safely and effectively.
The FDA monitors cosmetic products on the market and takes action if safety issues arise. However, post-market surveillance for cosmetic products is generally less stringent compared to drugs. Also, the FDA inspects manufacturing facilities and does sample testing.
Post-market surveillance for drugs is extensive, with adverse event reporting, monitoring for potential safety concerns, facility inspections, and enforcement actions to address non-compliance.
Cosmetics are all about enhancing beauty, promoting attractiveness, and bringing out the best in our appearances, without interfering with the body’s functions. In contrast, drugs serve a more profound purpose, offering remedies, treatments, and preventions for various medical conditions that impact our health and well-being.
As the beauty industry continues to evolve, staying informed about whether your product is a cosmetic, a drug, or both thereof ensures a thriving and compliant market, where safety and efficacy reign supreme.
Contact us now if you are struggling to determine whether your product is a drug or cosmetic or both.
- Is there any FDA classification for cosmetic products? No, there is no classification defined by the FDA for cosmetics.
- Do ingredients determine whether a product is classified as a cosmetic or a drug? Yes, ingredients influence the classification. For instance, if an ingredient is meant to treat or cure a specific medical condition, the product would likely be considered a drug. On the contrast, if an ingredient primarily serves a beautifying or aesthetic purpose, the product would fall under the cosmetic category.
- Is it possible for a product to be categorized as both a cosmetic and a drug in the USA? Yes. This can happen when a product has both cosmetic and therapeutic claims. In such cases, the manufacturer has to comply with both drug and cosmetic regulations.
- What are exemptions under MoCRA? MoCRA provides exemptions to specific small businesses, relieving them from adhering to Good Manufacturing Practices (GMP), registration, and product listing requirements.
- Are there any penalties for misclassifying a product as a cosmetic or drug? Misclassifying a product can have serious consequences, including regulatory action, recalls, fines, and damage to a company’s reputation. Ensuring precise classification is essential for businesses to prevent such penalties.
Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.